Bio-Rad is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Bio-Rad - FDA 510(k) Cleared Devices
Recent clearances: MRSASelect II, VRESELECT CULTURE MEDIUM, VRESELECT CULTURE MEDIUM
319
Total
319
Cleared
0
Denied
Bio-Rad has 319 FDA 510(k) cleared medical devices. Based in Mchenry, US.
Historical record: 319 cleared submissions from 1976 to 2017. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Bio-Rad Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by MDC Associates, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Bio-Rad
319 devices
Cleared
Dec 28, 2017
MRSASelect II
Microbiology
262d
Cleared
Nov 06, 2012
VRESELECT CULTURE MEDIUM
Microbiology
105d
Cleared
Oct 21, 2011
VRESELECT CULTURE MEDIUM
Microbiology
308d
Cleared
Jan 13, 2011
PLATELIA ASPERGILLUS EIA MODEL 62793
Microbiology
412d
Cleared
Oct 29, 2010
MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS
Microbiology
241d
Cleared
Jun 26, 2008
PLATELIA LYME IGM
Microbiology
42d
Cleared
Jun 13, 2008
MRSASELECT - EXTENDED INCUBATION
Microbiology
45d
Cleared
May 08, 2008
PLATELIA LYME IGG ASSAY
Microbiology
126d
Cleared
Sep 13, 2007
MRSASELECT
Microbiology
218d
Cleared
Jun 02, 2006
PLATELIA ASPERGILLUS EIA, MODEL 62793
Microbiology
84d
Cleared
Nov 09, 2005
LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4
Chemistry
33d
Cleared
Aug 09, 2005
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
Toxicology
11d
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